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OpenTrials
Completed

NCT Number: NCT02631681

Supervised Group Based Exercise for Men With Prostate Cancer on Androgen Deprivation Therapy

Exercise intervention for men with prostate cancer on androgen deprivation therapy.

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Key information

Conditions

Prostatic Neoplasms Androgen Deprivation Therapy Exercise Therapy Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Herlev and Gentofte Hospital

Herlev, Please Select An Option Below, 2100, Denmark

About this study

The aim of the project is to investigate the effects of patient education and exercise intervention implemented in daily clinical practice for men with prostate cancer on androgen deprivation therapy

  • Functional capacity
  • Quality of life
  • Body composition
  • Blood pressure

and to assess safety of progressive resistance training for participants with bone metastases.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a prostate cancer diagnosis on androgen deprivation therapy

Exclusion criteria

  • Opioid demanding treatment for skeletal pain
  • Eastern Cooperative Oncology Group performance status > 2
  • Inability to perform floor and machine exercises independently

Treatment and study plan

Group based exercise

Behavioral

Supervised group based combined aerobic and resistance training for 12 weeks as part of our normal clinical practice.

Primary outcomes

  1. Change in 30second Chair-Stand test (30s-CST)

    Time frame: Baseline, 12 and 24 weeks

    Test of functional capacity, measured as change

  2. Change in Graded Cycling Test with Talk Test (GCT-TT)

    Time frame: Baseline, 12 and 24 weeks

    Test of functional capacity, measured as change

Secondary outcomes

  1. change in QoL

    Time frame: Baseline, 12 and 24 weeks

    European Organisation for Research and Treatment of Cancer (EORTC) cancer and prostate specific questionnaires: EORTC QLQC-30 version 3.0 and PR25

  2. change in Body composition

    Time frame: Baseline, 12 and 24 weeks

    BMI, waist and hip circumference, waist-hip ratio.

  3. change in Bloodpressure

    Time frame: Baseline, 12 and 24 weeks

    Systolic and diastolic bloodpressure

  4. Safety of exercise assessed by serious adverse events according to the FDA

    Time frame: Study period baseline - 24 weeks

  5. Compliance assessed by attendance and continued exercise (yes/no)

    Time frame: Baseline, 12 and 24 weeks

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 16, 2015
Registry last updated
Aug 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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